BURLINGTON,
Mass., May 1, 2024 /PRNewswire/ -- BrioHealth
Solutions, Inc., a medical technology company focused on developing
innovative advanced heart failure solutions, today announced it has
received FDA Investigational Device Exemption (IDE) approval with
conditions to commence enrollment in its landmark INNOVATE trial.
The study will assess the effectiveness and safety of its novel
BrioVAD™ System, a magnetically levitated ventricular assist
device, in treating refractory left ventricular heart failure. With
the notice, BrioHealth Solutions has initiated clinical site
start-up activities in the US.
The BrioVAD Left Ventricular Assist System is
designed to aid patients suffering from advanced heart failure,
offering both temporary and long-term support solutions. The
BrioVAD System consists of a novel hemocompatible blood pump with a
fully magnetically levitated rotor and two small, lightweight,
patient-worn components. This advanced technology is designed to
help patients overcome the limitations of heart failure and enhance
quality of life. The BrioVAD system will be evaluated in the
INNOVATE trial randomized relative to technology previously
approved by the FDA.
"Achieving this stage of FDA approval for the
INNOVATE trial marks an important step in providing more options to
clinicians and patients seeking advanced heart failure therapies,"
said Francis D. Pagani, M.D., Ph.D., the Otto Gago MD Endowed
Professor in Cardiac Surgery at the University
of Michigan and the study's National Principal Investigator.
"The clinical evaluation of the BrioVAD System is a
significant leap forward for the entire field of heart failure.
Countless patients go untreated each year and continue to suffer
with this seriously debilitating condition," Dr. Pagani
emphasized.
"We are excited to have achieved this crucial
milestone. Our goal is to deliver patient-centered solutions for
advanced heart failure patients and their families," remarked
Chen Chen, Ph.D. CEO of BrioHealth
Solutions. "The innovative BrioVAD System, with its compact
pump designed for hemocompatibility along with small, lightweight
peripherals, has been engineered to restore patients back to active
lifestyles."
About BrioHealth Solutions:
BrioHealth
Solutions is developing the BrioVAD™ System, a left ventricular
assist system representing a significant advanced heart failure
innovation. The company's founding mission is a commitment to
restoring, extending and enhancing the lives of patients globally
by collaborating with healthcare providers to push the boundaries
of what's possible and deliver the best medical technologies and
solutions. The BrioVAD System is an investigational device limited
by federal law for investigational use only.
For more information on BrioHealth Solutions,
please visit the company website at www.briohealthsolutions.com and
follow us on LinkedIn @BrioHealthSolutions and Twitter/X
@BrioVAD.
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SOURCE BrioHealth Solutions, Inc.